Services
Integrated Product Development Support Services
At the heart of a successful medical device or combination product launch is regulatory approval. Our Integrated Product Development Support Service provides resources to support you in design history file (DHF) document creation and maintenance, risk analysis including Design (dFMEA) and Usability (uFMEA) Failure Modes Effects Analysis, design verification/validation protocol/report creation, project management, systems engineering, and design review execution. Our team members work alongside your team to meet your project requirements and within your Quality Management System (QMS) to ensure timely completion of project deliverables that are ready for the regulatory review process.
New Product Development Strategy Creation
From insight to innovation. That is what we are all about. Our New Product Development Strategy Creation service offers an opportunity to engage new product teams in cross-functional stakeholder exercises that generate diverse information datapoints and key insights that result in innovative market solutions. From hands-on workshops to developing product profiles, our team works closely with your internal teams to document all outcomes and present a final actionable strategy.
Digital Health Strategy Assessment
Digital Health (or Connected Health) is increasingly becoming an integral part of any new medical device or combination product launch. In order to maximize the usefulness and adoption of the digital health solution, it is important that a well developed digital health strategy be developed in parallel with the product development lifecycle. This provides the opportunity to begin introducing your digital health solution at the earliest points possible, including early clinical trials. Our Digital Health Strategy Assessment service offers the opportunity to engage in hands-on digital health workshops that present a user value-based approach to your solution, including assessment of the overall intended digital health ecosystem.